Ultrasound Guided Probe Device and Method of Using Same

ABSTRACT

The present invention is directed to devices and methods for use in ultrasound guiding of percutaneous probes during medical procedures. The ultrasound devices of the present invention include an ultrasound transducer. The devices can also include means and methods for imaging a virtual probe overlaying the sonogram formed by the ultrasound device such that a real time image of the probe approach to the target may be observed during and after probe placement.

BACKGROUND OF THE INVENTION

Medical probe devices are utilized for many purposes, chief of whichinclude catheterization, centesis, and biopsy procedures. Percutaneousplacement of probes using these devices is often performed withtechniques which rely on palpable or visible structures. This is neithera simple nor a risk-free procedure. For instance, proper insertion andplacement of a percutaneous probe depends on correct localization ofanatomical landmarks, proper positioning of the patient in relation tothe care provider, and awareness of both the target's depth and anglefrom the point of probe insertion. Risks of unsuccessful placement of aprobe can range from minor complications, such as patient anxiety anddiscomfort due to repetition of the procedure following incorrectinitial placement, to severe complications, such as pneumothorax,arterial or venous laceration, or delay of delivery of life-savingfluids or medications in an emergency situation.

Ultrasound guided techniques and devices have been developed to aid incorrect placement of percutaneous probes, Ultrasound guided techniquesusually require two people, an ultrasound operator who locates theinternal target and keeps an image of the target centrally located on amonitor, and a care provider who attempts to guide the probe to thetarget based upon the sonogram. Such techniques are very difficultperceptually. For instance, these techniques are complicated by the factthat the person targeting the tissue with the probe is not the sameperson as is operating the ultrasound. in addition, the generally thin,cylindrical probe is usually small and reflects very little of theultrasound beam. Moreover, as the cylindrical probe and the ultrasoundbeam are not generally normal to one another, the small amount ofultrasonic energy that is reflected from the probe will reflect at anangle to the incident beam, resulting in little if any of the reflectedenergy being detected by the ultrasound transducer. As a result, theprobe itself is difficult to visualize in the sonogram and the personplacing the probe must attempt to guide the probe to the correctlocation using minimal visual feedback provided by the ultrasoundoperator physically rocking the ultrasound transducer. Rocking thetransducer allows the observer to see a series of planar sonograms ofthe internal region, and, with training, the observer can learn torecognize subtle changes in the sonograms as the probe deflects andpenetrates the surrounding tissue and pick up subtle ultrasonic shadowartifacts deep to the probe created when the probe blocks thetransmission of the ultrasound beam to the tissue below.

In an attempt to relieve the difficulties of ultrasound guided probetechniques, systems have been developed including a probe guide whichcan be attached to an ultrasound transducer housing. Problems stillexist with such devices however. For instance, the probe guide is to oneside of the ultrasound transducer housing in these devices, and theprobe is often inserted at a fixed angle to the plane of the ultrasoundbeam displayed on the sonogram, restricting the intersection of theultrasonographic beam and the point of the probe to a very small area inspace. In addition, and as with hand-guided ultrasound techniques, verylittle, if any, ultrasonic energy is reflected from the probe back tothe transducer. In fact, due to the angle between the incidentultrasonic beam and the probe in these devices, visual cues to thelocation of the probe tip may be even more difficult to discern on asonogram when using these devices. In addition, in many of thesedevices, the probe passes through the ultrasound beam at a fixed depthrange depending on the set angle of the probe guide, and this may notcorrespond to the depth of the target, in which case it may not bepossible to show the juncture of the target and the probe tip on thesonogram at all.

What is needed in the art is an improved device and method for utilizingultrasound to guide a probe to a percutaneous target.

Another problem that exists when attempting to place a percutaneousprobe concerns movement of the probe following correct placement. Forinstance, after successfully placing a probe, in many procedures it isdesirable for the probe tip to remain at the target location for aperiod of time, for instance as a catheter wire is inserted or a biopsytaken. Often, a small movement of the hand holding the probe in placecan cause the probe tip to shift away from the target, leading tocomplications. Thus, what is needed in the art is a device and methodthat can clamp a probe following placement in order to limit motion ofthe probe tip within the body.

Yet another on-going problem faced by medical professionals everywhereis maintenance of a sterile field during procedures. Thus, what isadditionally needed in the art is the ability to maintain a sterilefield while utilizing ultrasound guided probe devices and methods.

SUMMARY OF THE INVENTION

For purposes of this disclosure, the term “probe” is herein defined tobe device that can be guided by and used in conjunction with theultrasound devices of the present invention. For example, the term“probe” can refer to a needle, a tube, a biopsy device, or any otheritem that can be guided by the devices as herein described.

In addition, the term “probe device” is herein defined to be a devicethat can be utilized with a probe, but does not necessarily include theprobe itself.

In one embodiment, the present invention is directed to a probe devicethat can include an ultrasound transducer housing which can include anultrasound transducer for transmitting an ultrasonic beam. Theultrasound transducer housing can define a probe guide opening throughthe base of the housing. The probe guide opening can pass through thearea defined by the ultrasound transducer or outside of this area,depending upon the desired characteristics of the system.

The device can, in one embodiment, also include a sterile seal that canbe removably attached to the ultrasound transducer housing. The sterileseal can include, for example, a sterile probe guide that can beremovably received within the probe guide opening.

The sterile seal can also include a seal base, onto which the base ofthe ultrasound transducer housing can fit. In one embodiment, thesterile seal can include a sterile sleeve, which can be adapted forsubstantially covering the exterior of the ultrasound transducer housingwithout blocking movement of a probe through the probe guide. Forexample, the sterile sleeve can include a pliant, disposable materialsuch as a nonwoven web material or a thermoplastic material.

In one embodiment, the medical probe device can be a linear, noninvasiveprobe device incorporating a linear ultrasound array such as isgenerally known in the art for visualizing vascular targets. In oneparticular embodiment, the probe guide opening defined by the transducerhousing can be perpendicular to the flat base of the linear arraydevice. In another embodiment, the medical probe device can be a convexdevice, in which the array of elements forming the ultrasound transducerdefines an arcuate profile. In some embodiments, the base of the devicecan also define an arcuate profile that can correspond to the curvatureof the ultrasound transducer within the transducer housing. Such devicesare often common for visualizing large targets, such as organvisualization devices. In one particular embodiment of a convex probedevice, the probe guide opening can be perpendicular to the tangent ofthe base taken at the point where the probe guide opening passes out ofthe housing at the base.

The medical probe device of the present invention can include a clamp.In one particular embodiment, the clamp can be a mechanical clamp incommunication with the ultrasound transducer housing for clamping aprobe in the probe guide.

In another embodiment, the medical probe device can include a detector,such as a motion detector, in communication with a processing unit. Forexample, the detector can detect motion of a probe as it is guidedthrough the probe guide and communicate that information via a datastream to the processing unit. The processing unit can also be incontact with the ultrasound transducer and can be utilized to form thesonogram. The processing unit can use the information in the data streamto display information on a monitor relating the location of the probein relation to the target. For example, the data stream can be utilizedto form a real time virtual image of the probe as it moves through thefield and display an image of the probe on the sonogram. In general, inthis embodiment, the path of the probe can define a line that isparallel to the plane displayed on the sonogram.

In one embodiment, rather than or in addition to information concerningthe real time location of the probe, information concerning the probepath can be displayed on the monitor. For example, a targeting lineshowing the path the probe will take, which is parallel to the plane ofthe sonogram, can be displayed on the monitor.

In another embodiment, the present invention is directed to a sterileseal that may be utilized in conjunction with an ultrasound device. Forexample, the sterile seal can include a sterile probe guide for use withan ultrasound device in order to provide a sterile barrier between theultrasound transducer housing and a probe guided through the housing.The sterile probe guide can, in one embodiment, include separable topand bottom portions which can be attached together when the seal isreceived within the probe guide opening that is defined by theultrasound transducer housing. In one embodiment, the sterile seal caninclude a sterile sleeve continuous from the sterile probe guide thatcan substantially enclose the ultrasound transducer housing withoutblocking motion of a probe through the sterile probe guide. For example,the sterile sleeve can comprise a pliant material that can wrap theultrasound transducer housing and/or the sleeve can comprise anon-pliable base that can cover one or more surfaces of the transducerhousing. In one embodiment, a clamp for clamping a probe in the sterileprobe guide can be integral to the sterile seal.

The presently disclosed devices may be utilized in a variety of medicalprocedures. For example, the devices may be utilized to target bloodvessels, tissue masses, or fluid-filled cavities. In one particularembodiment of the present invention, the devices may be utilized duringcentral venous catheterization procedures.

BRIEF DESCRIPTION OF THE FIGURES

A full and enabling disclosure of the present invention, including thebest mode thereof to one of ordinary skill in the art, is set forth moreparticularly in the remainder of the specification, including referenceto the accompanying figures in which:

FIG. 1 illustrates one embodiment of an ultrasound transducer housing ofthe present invention;

FIG. 2 illustrates one embodiment of a sterile seal according to thepresent invention including separable top and bottom portions;

FIG. 3 illustrates one embodiment of a device of the present inventionincluding an ultrasound transducer housing enclosed by a sterile seal soas to form a sterile probe guide within the probe guide opening that isdefined by the ultrasound transducer housing;

FIG. 4 illustrates an isometric view of one embodiment of the top of asterile seal probe guide according to the present invention including anintegral clamp;

FIG. 5 shows a cut-away plan view of the probe guide of FIG. 4 takenalong line V-V.

FIG. 6 illustrates a clamping lever suitable for use with the probeguide of FIG. 4;

FIG. 7 shows a plan view of the clamping lever of FIG. 6 taken alongline VII-VII;

FIGS. 8A and 8B are cut-away plan views of a probe held by the clamp ofFIGS. 4-7 in both an unclamped position (FIG. 8A) and a clamped position(FIG. 8B);

FIG. 9 illustrates another embodiment of the present invention in whichan image of a virtual probe may be correlated with a sonogram;

FIGS. 10A-10F are planar views of embodiments of ultrasound transducersof the present invention, showing a variety of relationships between theultrasound transducer and a probe guide opening defined by thetransducer housing;

and

FIG. 11 illustrates another embodiment of the ultrasound transducerhousing of the present invention including a convex ultrasoundtransducer.

Repeat use of reference characters in the present specification anddrawings is intended to represent the same or analogous features ofelements of the invention. Other objects, features and aspects of thepresent invention are disclosed in or are obvious from the followingdetailed description.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Reference will now be made in detail to various embodiments of theinvention, one or more examples of which are set forth below. Eachembodiment is provided by way of explanation of the invention, notlimitation of the invention. In fact, it will be apparent to thoseskilled in the art that various modifications and variations may be madein the present invention without departing from the scope or spirit ofthe invention. For instance, features illustrated or described as partof one embodiment, may be used in another embodiment to yield a stillfurther embodiment. Thus, it is intended that the present inventioncover such modifications and variations as come within the scope of theappended claims and their equivalents.

The present invention is directed to improved devices and methods foruse in guiding percutaneous probes during medical procedures. Morespecifically, the ultrasound devices of the present invention include anultrasound transducer housing having an opening therethrough configuredto accommodate a probe. In one embodiment, the opening can serve as aprobe guide. Optionally, the opening can be configured to accommodate aremovable probe guide for the probe.

Using the presently disclosed devices, the path of a probe guidedthrough the device and hence the location of the probe tip can be moreclearly known in relation to a target imaged by the ultrasound device.In addition, in one preferred embodiment, the presently discloseddevices can be utilized by a single operator who can control both theultrasound transducer and the probe during the procedure.

Using the presently disclosed devices, a probe tip can be guided to apercutaneous target on a line that is parallel to the plane imaged onthe sonogram. That is, either within the plane imaged on the sonogram oradjacent to it, but in either case parallel to it. When utilizing thepresently disclosed devices, the path of the probe to the target can beknown, even if it cannot be discerned on the sonogram: the probe willadvance toward the target on a straight line and at a predeterminedangular relationship to the ultrasound housing base from the probe guideopening that is defined by the transducer housing, past the exit of theprobe guide opening, and, while traveling parallel to a plane that canbe imaged on a sonogram, to the target that is imaged by the ultrasound.Thus, the path of the probe and the sonogram image can both be definedby the orientation of the transducer and can be coordinated on thetarget. In order to strike the target, the probe can be merely guidedalong this known path the desired distance. In one particular embodimentof the invention, the path of the probe can be perpendicular to the baseof the ultrasound transducer housing at the probe guide opening exit. Byuse of the disclosed targeting devices, the guesswork and difficultiesof previously known ultrasound guided procedures due to the anglebetween the advancing probe and the image formed by the ultrasonic beamcan be removed.

In one embodiment of the present invention, the targeting process can beeven further improved by the creation of an image of the known path oftravel of the probe or an image of the advancing probe itself, a‘virtual probe’, either of which can overlay the sonogram formed by theultrasound device. In one particular embodiment, a motion detector canregister motion of a probe in the probe guide, and that information canbe displayed, for instance, as a real time image of the probe on ascreen or monitor. In this embodiment, the location of the probe tip inrelation to the target and the moment when the probe tip strikes thetarget can be seen in real time by an operator watching the virtualprobe on the monitor during the procedure.

In one embodiment, the presently disclosed invention is directed to asterile seal which can cover surfaces of an ultrasound transducerhousing that may be near the patient and/or the probe. Beneficially, thesterile seal of the present invention can include a sterile probe guide.During the procedure, the sterile probe guide can be located within theprobe guide opening that passes through the ultrasound transducerhousing. During a probe insertion procedure, the probe can pass throughthe sterile probe guide and not come into contact with the ultrasoundtransducer housing. The presence of a sterile barrier between theultrasound transducer housing and the probe during the procedure cangreatly enhance patient safety by prevention of infection. In addition,in one embodiment, the sterile seal can include a sleeve tosubstantially cover the ultrasound transducer housing. Thus, due to thepresence of the sterile seal, the ultrasound transducer housing andrelated equipment need not be sterilized after a procedure, and can beready to be used again with a new sterile seal after a simple cleansingprocedure. As such, a single ultrasound transducer may be used morefrequently, making the devices much more economical.

A removable probe guide is not a requirement of the present devices,however. In other embodiments, the probe guide may be the probe guideopening. In any case, the presently disclosed devices can be utilized toguide a probe on a known path of travel from the housing itself directlytoward a target.

It should be understood as well that the sterile seal of the presentinvention, while particularly well suited for use with the ultrasounddevices as herein disclosed, can also be utilized with other ultrasoundtransducers in which a probe guide opening is defined by the ultrasoundtransducer housing.

Following successful insertion of a percutaneous probe to a target, manyprocedures require the probe to remain at the target for a period oftime. For example, during the Seldinger technique common for centralvenous catheter placement, a cannulated needle attached to a syringe isfirst guided into a vein. After the needle tip is in the lumen of thevein, the needle is held while the syringe is removed from the needleand a guide wire is fed down through the needle and into the vein.During this process, only a slight movement of the needle can cause theneedle tip to move out of the vein, and the entire procedure must berepeated.

In order to prevent such motion of the probe tip following insertion toa target, one embodiment of the present device includes a clamp for theprobe. In this embodiment, the device can include a clamp which canfirmly hold the probe in relation to the ultrasound transducer housingand prevent motion of the probe during subsequent procedures such ascatheter insertion, biopsy procedures, fluid or gas aspiration, or thelike. As the ultrasound transducer housing can be much easier to hold inplace during such procedures as compared to holding only the smallprobe, motion of the probe tip can be much less likely when the probe issecurely clamped in relation to the ultrasound transducer housing andthe transducer housing is held in the hand and further stabilized bypatient contact as compared to when only the probe by itself is held inthe hand

In accord with the present invention, FIG. 1 illustrates one embodimentof an ultrasound transducer housing generally 100 according to thepresent invention. In this embodiment, the transducer housing includesan ultrasound transducer generally 120 that transmits and receivesultrasonic waves. The ultrasound transducer 120 can be any type ofultrasound transducer as is generally known in the art. For example, inone embodiment, the ultrasound transducer can be a piezoelectrictransducer formed of one or more piezoelectric crystalline materialsarranged in a two or three-dimensional array. Such materials includeferroelectric piezoceramic crystalline materials such as lead zirconatetitanate (PZT). In one embodiment, the elements that form the array canbe individual electrode or electrode segments mounted on a singlepiezoelectric substrate, such as those described in U.S. Pat. No.5,291,090 to Dias, which is incorporated herein by reference thereto. Ingeneral, the ultrasound transducer 120 can be formed of multipleelements, however, single crystal devices are also encompassed by thepresent invention.

The use of multiple element ultrasound transducers can be advantageousin certain embodiments, as the utilization of multiple elements canprovide an ultrasound transducer in which the individual elements thatmake up the array can be controlled so as to limit or prevent any breakor edge effects in the sonogram which could otherwise occur in thoseembodiments wherein the probe guide opening passes through thetransducer, e.g., a break in the array of elements forming thetransducer, For instance, in the present devices, the firing sequence ofthe individual crystals can be manipulated through various controlsystems and prevent any possible ‘blind spots’ in the sonogram as wellas to clarify the edges of individual biological structures in thesonogram, Such control systems are generally known in the art and thuswill not be described in detail.

Ultrasound transducer housing 100 defines a probe guide opening 126 thatis substantially perpendicular to both the base 128 of the ultrasoundtransducer housing 100 as well as to the plane of the linear ultrasoundtransducer 120. As such, in this particular embodiment, a probe that isguided through the probe guide opening 126 can travel parallel to theplane of a sonogram formed by the device and coincident with thedirection of the emitted ultrasonic beam. Thus, in this illustratedembodiment, when the ultrasound transducer housing is centered over thetarget, the probe can merely be guided straight down through the fieldto the depth of the target, and the operator can be assured of strikingthe target with the probe, as there is no angle of approach between theprobe and the target in relation to the direction of the emittedultrasonic beam.

Generally, the ultrasound transducer 120 can be connected via signalwires with a cable 124 that leads to a processing unit which processesthe data to form a sonogram on a monitor, as is generally known in theart. In the particular embodiment as illustrated in FIG. 1, cable 124 isinternal to handle 122 of the ultrasound transducer housing 100, thoughthis is not a requirement of the invention. Handle 122 can generally beset at an angle to the base 128 of transducer housing 100 so as to becomfortably held in the hand while the device is being utilized.

As can be seen, in this particular embodiment, ultrasound transducer 120is a linear array that is discontinuous across the base 128 ofultrasound transducer housing 100 at probe guide opening 126. A probecan be guided through probe guide opening 126 and past ultrasoundtransducer 120 in a path that is substantially perpendicular toultrasound transducer 120.

In other embodiments, the geometric arrangement of the ultrasoundtransducer may be varied, as can the location of the probe guide openingin relation to the transducer, as long as the probe guide opening isdefined by the ultrasound transducer housing and passes through the baseof the transducer housing. For example, while not meant to be in any waylimiting, FIGS. 10A-10F illustrate plan views of several exemplaryorientations for ultrasound transducers 120 of the disclosed devices aswell as relative locations for probe guide openings 126 through the base128 of the transducer housing. FIG. 10A includes a generally circularultrasound transducer 120. In this embodiment, the probe guide opening126 can pass through the area enclosed by the transducer, but at thecenter, such that there is no break in the transducer itself.Alternatively, as shown at FIG. 10B the probe guide opening 126 can passthrough the ultrasound transducer 120 at a break in the transducer. FIG.10C illustrates another possible geometric arrangement for thetransducer. In this embodiment, the ultrasound transducer 120 isgenerally of a T-shape, with the probe guide opening 126 at the centerof the intersection of the two linear portions of the ultrasoundtransducer 120. In yet another alternative embodiment, shown in FIG.10D, the ultrasound transducer 120 is rectangular, with the probe guideopening 126 at the center of the rectangular array. FIG. 10E illustratesanother embodiment in which the ultrasound transducer 120 is comprisedof two separated sections, with the probe guide opening 126 between thetwo sections of the array. In yet another embodiment, the probe guideopening 126 can be outside the area defined by the ultrasound transducer120, though the path of a probe through the probe guide opening canstill be parallel to the plane of the sonogram formed by the transducerin this embodiment. Any suitable planar geometric arrangement for theultrasound transducer is encompassed by the disclosed devices, as is thelocation of the probe guide opening in relation to the ultrasoundtransducer

In addition, the presently disclosed devices are not limited to lineartransducers, such as illustrated in FIG. 1. In another embodiment, asillustrated in FIG. 11, the ultrasound transducer can be a convextransducer, such as is commonly used in procedures in which largertargets are imaged by the devices. Convex transducers are common, forexample, in prenatal ultrasound devices and large organ scanningdevices. Such devices include an ultrasound transducer having an arcuateprofile, such that the ultrasound beam emitted by the device fans out ina wider field. FIG. 11 illustrates one embodiment of a convex ultrasounddevice according to the present invention. As can be seen, ultrasoundtransducer housing 200 has a convex base 228. Within ultrasoundtransducer housing 200 is ultrasound transducer 220, which has anarcuate profile, as shown. Ultrasound transducer housing 200 defines aprobe guide opening 126 that passes through the transducer housing 200,through the arcuate base 228, and, in this particular embodiment,through the arcuate ultrasound transducer 220. In this particularembodiment, probe guide opening 126 is perpendicular to the tangent ofthe arcuate base 228 at the exit of probe guide opening 126. In otherembodiments, the probe guide opening may alternatively be at a differentangle to the tangent of the base at the opening and may be in adifferent orientation to the probe guide opening, as described above inrelation to linear transducers.

Referring again to FIG. 1, transducer housing 100 defines probe guideopening 126 that passes through ultrasound transducer 120. Probe guideopening 126 can include recessed portions 111 where the dimensions ofprobe guide opening 126 are slightly increased along a short portion ofthe length of the probe guide opening 126. Recessed portions 111 can beused to hold a removable probe guide in the probe guide opening, as willbe further disclosed herein.

It should be understood that any particular geometric configuration fortransducer housing 100 and its individual sections is not essential tothe present invention. For instance, though FIG. 1 illustrates bothultrasound transducer housing 100 and probe guide opening 126 both witha substantially cylindrical shape, any other shape could be equallyutilized. For example, the base 128 of transducer housing 100 may beoblong, square, or any other suitable shape. In addition, ultrasoundhousing 100 may extend substantially vertically when placed on asurface, as shown in the figures, or may be canted at an angle when thebase 128 is placed flat on a surface. In certain embodiments, the shapeof ultrasound housing 100 may be particularly designed to fit specificlocations of the anatomy. For example, ultrasound housing 100 may beshaped to be utilized specifically for infraclavicular approach to thesubclavian vein, approach to the internal jugular vein, or some otherspecific use.

In addition, though in preferred embodiments probe guide opening 126 canbe perpendicular to the flat linear base 128 of a linear transducerhousing as shown in FIG. 1 this is not a requirement of the invention.In other embodiments, the probe guide opening defined by the ultrasoundtransducer housing and passing through the ultrasound transducer housingbase can be at some other angle to the base at the probe guide opening.

In one embodiment, probe guide opening 126 can serve as a probe guidefor a probe directed to a target. In another embodiment, a removableprobe guide can be placed in the probe guide opening. For example, oneembodiment of the present invention includes a sterile seal including asterile probe guide that can be removably attached within the probeguide opening of a transducer housing. FIG. 2 illustrates one particularembodiment of a sterile seal, generally, 110 that can be utilized incooperation with ultrasound transducer housing 100 to provide a sterilebarrier between a patient and the ultrasound transducer housing 100during a medical procedure. Sterile seal 110 includes separable toppiece, generally, 112 and bottom piece, generally, 114. Sterile seal 110can be formed of a number of different materials which can besterilized. For instance, sterile seal 110 can be formed of sterile,single-use materials as are generally known in the art such that theentire sterile seal 110 can be properly disposed of following a singleuse.

Sterile seal 110 includes bottom piece 114 that includes a seal base 116formed of an ultrasonic transmissive material. Seal base 116 can be ofany suitable size and shape. In general, seal base 116 can be betweenabout 0.5 inches and about 6 inches on its greatest length. For example,the seal base 116 can be about 0.5 inches on its greatest length so asto promote stability of the device during use. In other embodiments, itcan be larger, however, such as about 1 inch on its greatest length,about 2 inches on its greatest length, or even larger. In addition, sealbase 116 can generally be of the same geometric shape as the base 128 ofultrasound transducer housing 100 in order that ultrasound transducerhousing base 128 may be seated firmly in seal base 116 and not slideabout during use.

Arising out of seal base 116 is lower portion 118. Lower portion 118defines a portion of probe guide 119 therethrough. Probe guide 119extends completely through both lower portion 118 and seal base 116.Lower portion 118 includes a lower section 121 having a cylindricalexterior and an upper section 130 having a smaller cylindrical exterior.Section 130 may include a removable cap 127 for protection of thesterile surface of probe guide 119 during assembly of sterile seal 110with ultrasound transducer housing 100. Lower portion 118 also includestabs 117 that can be utilized when assembling sterile seal 110 withultrasound transducer housing 100, as will be further described herein.

The bottom piece 114 of sterile seal 110 also includes sterile drape132. Sterile drape 132 can be glued or otherwise attached to seal base116. Sterile drape 132 can generally be formed from any of a number ofsuitable flexible, pliant materials such as woven or nonwoven webmaterials commonly used for sterile drapes or sheeting, or may be formedof any other suitable sterilizable, pliant natural or syntheticmaterial. Sterile drape 132 is shown in a rolled configuration in FIG.2. Sterile drape 132 can be unrolled to cover the upper surfaces of thetransducer housing 100 during assembly of sterile seal 110 withtransducer housing 100 and provide a portion of the sterile barrierbetween the transducer housing 100 and a patient during a procedure. Inthis embodiment, sterile drape 132 and sterile base 116 together form asterile sleeve continuous from one end of the sterile probe guide 119that can substantially cover the outer surfaces of an ultrasoundtransducer housing 100.

Sterile seal 110 also includes top piece 112. Top piece 112 includesupper portion 123 defining an upper section of probe guide 119 at oneend of upper portion 123 and a slightly larger passage 125 continuouswith and below the upper section of probe guide 119. The larger passage125 is sized so as to snugly reside over upper section 130 of lowerportion 118 with the base 134 of upper portion 123 sitting on the top ofsection 121 when top piece 112 and bottom piece 114 are combined duringassembly of sterile seal 110. In order to assemble sterile seal 110, cap127 can be removed from section 130 of lower portion 118, and upperportion 123 may slide over lower portion 118 to form uninterrupted probeguide 119 extending from the top of top piece 112 all the way throughthe seal base 116 of the bottom piece 114. Top piece 112 also includesshield 135 and tabs 117, the use of which can be further understood withreference to FIG. 3.

FIG. 3 illustrates a cut-away view of one embodiment of the presentinvention including ultrasound transducer housing 100 held within fullyassembled sterile seal 110 including top piece, generally, 112 andbottom piece, generally, 114 of sterile seal removably attached to eachother, In order to better understand the combined configurationillustrated in FIG. 3, the assembly process for this particularembodiment will now be described in detail.

Ultrasound transducer housing 100 defining probe guide opening 126 isseated in seal base 116 of sterile seal bottom piece 114 such that lowerportion 118 extends through transducer housing probe guide opening 126.Generally, section 130 of lower portion 118 will be covered with aprotective cap 127 (as seen in FIG. 2) during this portion of theassembly process. Lower portion 118 should generally be of a length suchthat after ultrasound transducer housing 100 has been seated on sealbase 116, lower portion 118 can pass completely through probe guideopening 126 with a portion of section 130 extending beyond the top ofultrasound transducer housing 100. Generally, a small amount of anultrasonic gel can be placed between transducer housing base 128 andseal base 116 during seating to prevent any air between the two andpromote transmission of the ultrasonic waves. As transducer housing 100is slid over lower portion 118, tabs 117 can slide or snap into recesses111, helping to lock together the sterile seal bottom piece 114 andtransducer housing 100. After ultrasound transducer housing 100 islocated on bottom piece 114 of sterile seal 110, sterile drape 132 canbe unrolled to cover the top of transducer housing 100 including atleast a portion of handle 122. Sterile drape 132 can define a smallopening of a size so as to allow that portion of section 130 whichextends beyond the top of ultrasound transducer housing 100 to passthrough the sterile drape 132 when unrolled. At this time, protectivecap 127 (not shown in FIG. 3) can be removed from lower portion 118 andupper portion 123 can be slid onto lower portion 118 and into thetransducer housing probe guide opening 126, such that passage 125 snuglyfits over section 130. Tabs 117 can snap or slide into recesses 111 andhelp lock sterile seal top piece 112 into transducer housing probe guideopening 126. Shield 135 can press sterile drape 132 against the top ofultrasound transducer housing 100 helping to ensure the sterile barrier.

Following the above described assembly process, probe guide 119 canextend continuously from the top of sterile seal top piece 112 throughthe seal base 116. Moreover, and of great benefit to the invention,probe guide 119 can be sterile and yet still within ultrasoundtransducer housing 100 such that the path of a probe guided throughprobe guide 119 can be known in relation to the sonogram formed by useof ultrasound transducer 120.

Following the procedure, sterile seal 110 can be disassembled merely byreversal of the assembly process. Tabs 117 can be retractable bypulling, twisting, or some other lever action, allowing the upperportion 123 and lower portion 118 to be removed from the probe guideopening,

It should be understood that the sterile seal of the present inventioncan be designed with particular characteristics so as to conform to anyshape for any ultrasound transducer housing as is known in the art. Forexample, in other embodiments, the upper and lower pieces of a sterileseal may be of unitary construction, and need not be removably attachedto each other but may rather integral with each other. In addition, asterile seal may consist of only a sterile probe guide as can be placedwithin the probe guide opening defined by a transducer housing. In otherembodiments, a sterile sleeve can be formed entirely of a pliant steriledrape that is continuous from one end of the sterile probe guide 119. Inother embodiments, a sterile sleeve can be formed of other materials,such as a formed thermoplastic material, for example. In such anembodiment, the sterile sleeve could, for instance, include non-pliabletop and bottom portions that could be snapped or otherwise attached toeach other to substantially cover an ultrasound transducer housing,while defining a passage therethrough such that movement of a probethrough the probe guide opening is not impeded by the presence of thesterile sleeve. Obviously, a great number of possible configurations ofthe sterile seal may be equally effective, the only requirement beingthat the sterile seal includes a sterile probe guide that can beremovably received within the probe guide opening of the transducerhousing.

In one embodiment, the ultrasound transducer housing may be hinged on anaxis, for instance an axis parallel with the probe guide opening. Inthis particular embodiment, the ultrasound transducer housing can have aclamshell like configuration that can close about a unitary sterileprobe guide or even to form the probe guide itself. In another possibleembodiment, the ultrasound transducer housing can have an open slotleading from an edge of the transducer housing to the transducer housingprobe guide opening. In this embodiment, a separable, unitary sterileprobe guide may be slid into the transducer housing probe guide openingfrom the side via this slot. The ultrasound devices of the presentinvention encompass any configuration in which the ultrasound transducerhousing defines a probe guide opening which passes through the base ofthe transducer housing.

According to one embodiment of the present invention, the ultrasoundprobe device may include a clamp. A clamp may be of any suitableconfiguration which may, in one embodiment, be in mechanicalcommunication with the transducer housing to firmly hold a probe in theprobe guide opening and limit or prevent motion of a probe tip. This maybe especially beneficial after insertion of a probe to an internaltarget when it is preferred to have as little motion of the probe tip aspossible during subsequent procedures. For example, during centralvenous catheterization, after initial puncture of the vein by thecannulated needle and prior to insertion of the long guide wire into thevein, motion of the probe tip can cause the tip to move out of the veinand necessitate repetition of the entire procedure.

FIGS. 4-6 illustrate one embodiment of a clamp of the present invention.Referring to the Figures, an isometric view (FIG. 4) and a cut away planview (FIG. 5) of the terminal end of an upper portion 423 is shown.Upper portion, generally, 423 has been designed to be fitted with aclamping lever 150 shown in FIGS. 6 and 7. In this particularembodiment, upper portion 423 can be formed of a material such as asomewhat pliant plastic material that can be deformed under pressure andreturn to its original shape after the pressure is removed. Upperportion 423 defines a cut out 138 which extends through the wall ofupper portion 423 to the depth of probe guide 119 and forms locking tab140. Upper portion 423 also includes a cap 142 which can flex so as toallow a clamping lever 150 to be removably attached to the upper portion423.

FIG. 5 illustrates the upper portion 423 of FIG. 4 in a cut-away planview taken along lines V-V. As can be seen, the exterior profile of thisportion of upper portion 423 is not circular. The profile of upperportion 423 includes a flat section 136. Flat section 136 extends aheight ‘h’ (as shown in FIG. 4) along a face of upper portion 423. Cutout 138, extending from the outer surface of upper portion 423 to probeguide 119 can also be seen in the Figures. Locking tab 140 is thatsection of upper portion 423 immediately adjacent to cut out 138, asshown.

FIGS. 6 and 7 illustrate a clamping lever 150 designed to slide over thecap 142 of upper portion 423. Clamping lever 150 includes a handle 152and defines a central passage 154. Clamping lever 150 can generally beof a height ‘h’ so as to snuggly fit beneath the cap 142 of upperportion 423. As can be more clearly seen in FIG. 7, passage 154 includesa flat section 137 extending from the interior surface wall of passage154 for a short distance.

FIGS. 8A and 8B illustrate this particular embodiment of a clamp of thepresent invention after assembly in a plan view. Clamping lever 150 canslide over the terminal portion of upper portion 423. Cap 142 (not shownin FIGS. 8A and 8B) can hold clamping lever 150 on upper portion 423while cannulated probe 156, can be held with a friction fit in probeguide 119 as it is slid through probe guide 119. After the probe tip hassuccessfully reached the internal target, clamping lever 150 can berotated, as shown by the arrow in FIG. 8A, to clamp the probe 156 withinprobe guide 119, as shown in FIG. 8B. As the clamping lever is rotated,flat section 137 of the clamping lever deforms locking tab 140 againstthe probe 156 so as to reduce the size of and/or deform probe guide 119and tightly secure the probe 156 within probe guide 119 and limit orprevent motion of probe 156.

The figures illustrate one particular embodiment of a clamp, but itshould be understood that other embodiments of a clamp are alsocontemplated for use with the presently disclosed probe devices, andspecific geometric shapes or arrangement of components are not criticalto the clamp of the present invention. For example, the clamp need notbe tightened with a rotating clamping lever, as described in theembodiment above, but may optionally be activated by use of a triggermechanism, a key, a push button, a screw, or some equivalent activationdevice. In one embodiment, a rotating clamping lever can include athreaded portion for tightening the clamp. For example, a rotatingmechanism can be used to tighten the clamp that includes machine threadsor pipe threads. Pipe threads may be preferred in one embodiment, aspipe threads can provide a secure attachment between portions of theclamp with little rotational distance required to tighten the clamp.Additionally, any suitable tensioning device could be utilized torestrict movement of the probe with respect to the transducer housing.For example, the clamp could include a set screw or a spring mechanismthat can push against the probe to secure the probe in the probe guide.Additionally, the clamp can secure the probe at any point along theprobe guide, near the top, as shown in the embodiment shown in thefigures or optionally farther down in the transducer housing. Moreover,the clamp can be integral to a sterile seal, as shown in the figures, orused only with the ultrasound device, when no sterile seal surrounds anypart of the ultrasound transducer housing. For instance, the clamp maybe integral to the transducer housing or removably attachable to theultrasound transducer housing.

In one preferred embodiment, the clamp can be manipulated by the sameperson as is holding the handle of the transducer housing. For instance,after insertion and placement of the probe tip at the internal targetwith one hand, the operator can clamp the probe in the device with theother hand, which is the same hand that is holding the transducerhousing at the skin surface. Thus, in this embodiment, the entiretargeting procedure may be carried out by a single individual.

Due to the basic mechanics of ultrasound devices and particularly ofthose of the present invention, when the probe passes through the probeguide and travels in the body and parallel to the plane imaged on thesonogram, the probe itself will be virtually invisible on the sonogram.In fact, in the embodiment wherein the probe guide is perpendicular tothe base of the transducer housing at the probe guide opening, the probecan travel coincident with the direction of the beam in which case itwill not be ‘seen’ at all by the ultrasound device. This is not aproblem in the disclosed devices, however, as the entire probe path isknown when looking at the sonogram. When looking at the sonogram, thebase of the transducer housing will be at or near the top edge of thesonogram. Since the point of exit of the probe from the base of thetransducer housing is known, and the angled relationship between thebase and the probe path (i.e. the probe guide angle to the base) isknown, the path the probe will take in the body is known. In order tostrike the subcutaneous target with the probe, the operator need onlyline up this known path with the imaged target.

In one embodiment of the present invention, the known path of the probecan be added to the sonogram, and the targeting procedures can be evenfurther simplified. For example, one embodiment of the present inventionincludes the addition of a targeting line on the sonogram extending fromthat point on the sonogram where the probe guide opening exits thehousing (or passes the transducer) and projecting across the ultrasonicfield in a straight line at the known angle. Thus, if this targetingline is made to intersect the target which is imaged by the device, theoperator can be confident that the probe is accurately directed to thetarget. In other embodiments, other targeting information can bedisplayed on the sonogram. For example, in one embodiment, informationshowing the approach of the probe to the target can be displayed. Forinstance, in one embodiment, a real time image of a virtual probe as ittravels along the known targeting line can be displayed on the sonogram.

FIG. 9 illustrates one embodiment of the present invention wherein animage of a virtual probe may be overlaid on a sonogram. In thisparticular embodiment, the ultrasound system can include a detector 158.Detector 158 can recognize and monitor the movement of probe 156 as itenters the ultrasound device and passes through probe guide 119 and intothe body. The probe 156 can then be imaged on a monitor 164 as probeimage 168. The monitor 164 can also show the sonogram 166.

A variety of different possible detectors as are generally known in theart may be utilized as detector 158. For instance, detector 158 canutilize infrared (IR), ultrasound, optical, laser, or other motiondetection mechanisms. In addition, the location of detector 158 is notcritical to the invention. In the embodiment illustrated in FIG. 9,detector 158 is located on shield 135 of the sterile seal 110. In otherembodiments, however, the detector may be located elsewhere in thesystem including, for example, integral to the transducer housing 100,or elsewhere external to the transducer housing 100, such as on aportion of the probe itself.

Signals from detector 158 can be reflected off of syringe 170 oralternatively reflected off of some other portion of probe 156 to createa data stream which can be sent to processing unit 162 via informationcable 159. Processing unit 162, which can be, for example, a standardlap top or desk top computer processor or part of a self-containedultrasound system as is known in the art, can be loaded with suitablerecognition and analysis software and can receive and analyze the streamof data from detector 158. The processing unit can also include standardimaging software as is generally known in the art to receive data fromthe ultrasound transducer via cable 124. Probe 156 can be of apredetermined length which can be input data entered into processingunit 162 by the user or can be preprogrammed into the system as adefault length. Thus, through analysis of the data stream received fromdetector 158 and from ultrasound transducer 120, processing unit 162 canbe programmed to calculate the relative position of the probe tip 157 inrelation to the ultrasound transducer 120, in relation to ultrasoundtransducer housing base 128, in relation to detector 158 or to any otherconvenient reference point. Processing unit 162 can communicate thisposition information digitally via cable 163 to monitor 164 and theinformation can be displayed on the monitor such as in a numericalformat or optionally as a real time image of a virtual probe 168 shownin conjunction with the sonogram 166 including an image 167 of thetarget, such as blood vessel 160.

In such a manner, the devices of the present invention can be utilizedto actually show the approach of the probe toward the target on themonitor throughout the entire procedure. In addition, in certainembodiments, the present invention can be utilized to ensure the probetip remains at the target during subsequent procedures. For example, inthose embodiments wherein the detector 158 monitors the motion of theprobe 156 via signals reflected off of probe 156, as long as probe 156remains ‘visible’ to detector 158, the image 168 of probe 156 can remainon the monitor 164. Thus, in this particular embodiment, even if syringe170 is removed to be replaced with a guide wire, as in a catheterizationprocedure, the image 168 of the probe 156 can remain on the monitor 164and any motion of the probe tip 157 in relation to the target 160 can benoted by an observer.

The presently disclosed ultrasound guided probe devices and methods maybe utilized in many different medical procedures. Exemplary applicationsfor the devices can include, without limitation

-   -   Central Venous Catheterization    -   Cardiac Catheterization (Central Arterial Access)    -   Dialysis Catheter Placement    -   Breast Biopsies    -   Paracentesis    -   Pericardiocentesis    -   Thoracentesis    -   Arthrocentesis    -   Lumbar Puncture    -   Epidural Catheter Placement    -   Percutaneous Intravascular Central Catheter (PICC) line        placement    -   Thyroid Nodule Biopsies    -   Cholecystic Drain Placement    -   Arthroscopic Procedures    -   Laparoscopy

Some of these exemplary procedures have employed the use of ultrasoundin the past, and all of these procedures, as well as others notspecifically listed, could utilize the disclosed ultrasound guideddevices to improve procedural safety as well as patient safety andcomfort, in addition to provide more economical use of ultrasounddevices. In addition, the presently disclosed devices may be utilizedwith standard probe kits already available on the market.

It will be appreciated that the foregoing examples, given for purposesof illustration, are not to be construed as limiting the scope of thisinvention. Although only a few exemplary embodiments of this inventionhave been described in detail above, those skilled in the art willreadily appreciate that many modifications are possible in the exemplaryembodiments without materially departing from the novel teachings andadvantages of this invention. Accordingly, all such modifications areintended to be included within the scope of this invention which isdefined in the following claims and all equivalents thereto. Further, itis recognized that many embodiments may be conceived that do not achieveall of the advantages of some embodiments, yet the absence of aparticular advantage shall not be construed to necessarily mean thatsuch an embodiment is outside the scope of the present invention.

1-130. (canceled)
 131. A system for use with an ultrasound device, thesystem comprising: a probe, the probe including a portion that iscapable of being detected by a detector that is a component of theultrasound device; and a sterilizable seal, the sterilizable seal beingadapted to enclose all or a portion of an ultrasound transducer housing,the sterilizable seal defining a probe guide therethrough, thesterilizable seal comprising multiple sections capable of assembly withone another.
 132. The system according to claim 131, wherein the probeis a needle, a biopsy needle, a tube, or a blade.
 133. The systemaccording to claim 131, further comprising a syringe for use inconjunction with the probe.
 134. The system according to claim 131,wherein the multiple sections of the sterilizable seal comprise a firstsection that defines a first portion of the probe guide and a secondsection that defines a second portion of the probe guide, and whereinupon assembly of the first section with the second section, the probeguide is formed through which a probe is capable of passing.
 135. Thesystem according to claim 131, the sterilizable seal comprising a clampfor clamping a probe in the probe guide.
 136. The system according toclaim 135, wherein the clamp is an integral part of the sterilizableseal.
 137. The system according to claim 131, wherein the sterilizableseal comprises a first non-pliable section and a second non-pliablesection removably attachable to one another.
 138. The system accordingto claim 131, wherein the sterilizable seal comprises a pliant material.139. A system for use with an ultrasound device, the system comprising:a probe; a syringe for use in conjunction with the probe, the syringeincluding a portion that is capable of being detected by a detector thatis a component of the ultrasound device; and a sterilizable seal, thesterilizable seal being adapted to enclose all or a portion of anultrasound transducer housing, the sterilizable seal defining a probeguide therethrough, the sterilizable seal comprising multiple sectionscapable of assembly with one another.
 140. The system according to claim139, wherein the probe is a needle, a biopsy needle, a tube, or a blade.141. The system according to claim 139, wherein the multiple sections ofthe sterilizable seal comprise a first section that defines a firstportion of the probe guide and a second section that defines a secondportion of the probe guide, and wherein upon assembly of the firstsection with the second section, the probe guide is formed through whicha probe is capable of passing.
 142. The system according to claim 139,the sterilizable seal comprising a clamp for clamping a probe in theprobe guide.
 143. The system according to claim 139, wherein the clampis an integral part of the sterilizable seal.
 144. The system accordingto claim 139, wherein the sterilizable seal comprises a firstnon-pliable section and a second non-pliable section removablyattachable to one another.
 145. The system according to claim 139,wherein the sterilizable seal comprises a pliant material.